Bavencio (avelumab) Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of Bavencio (avelumab). Bavencio is a programmed death ligand-1 (PD-L1) antibody primarily used to treat metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial carcinoma.
The FDA approved indications for Bavencio include metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial carcinoma. Merkel cell carcinoma is a rare, aggressive type of skin cancer. It is considered to be aggressive because it can grow quickly and spread and it returns after treatment. Primary treatment for Merkel cell carcinoma is surgery. Urothelial carcinoma is the most common type of bladder cancer and occurs in the urinary tract system, involving the bladder and related organs. The FDA also approved for use in advanced renal cell carcinoma as first-line therapy in combination with axitinib (Inlyta). NCCN Compendia and guidelines recommend the use of Bavencio as a 2A recommendation in endometrial cancer as a single agent as second-line treatment in recurrent or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. There are no references, but approval was based on extrapolation from the studies of prior FDA approved indications. NCCN Compendia and guidelines recommend the use of Bavencio in metastatic (stage IV) bladder cancer, specifically primary carcinoma of the urethra as a first-line maintenance regimen (NCCN 1) if there is no progression on first-line platinum containing chemotherapy (Powles 2020). NCCN Compendia also recommends as a NCCN 1 recommendation for the use of Bavencio in metastatic bladder cancer as monotherapy, in second-line therapy for those who are post-platinum therapy or who received a therapy other than platinum or a checkpoint inhibitor in first-line therapy (Apolo 2017). Other Uses The National Comprehensive Cancer Network (NCCN) gives a category 2A recommendation for Bavencio as useful in certain circumstances as single-agent therapy for multiagent chemotherapy-resistant gestational trophoblastic neoplasia. At this time, there is insufficient evidence to recommend such addition (You B, et al 2020).
Definitions and Measures Disease Progression: Cancer that continues to grow or spread. ECOG or Eastern Cooperative Oncology Group Performance Status: A scale and criteria used by doctors and researchers to assess how an individual’s disease is progressing, assess how the disease affects the daily living abilities of the individual, and determine appropriate treatment and prognosis. This scale may also be referred to as the WHO (World Health Organization) or Zubrod score which is based on the following scale: • • • • • • 0 = Fully active, able to carry on all pre-disease performance without restriction 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5 = Dead Immune checkpoint inhibitor: A type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. When these proteins are blocked, the “brakes” on the immune system are released and T cells are able to kill cancer cells better. Examples of checkpoint proteins found on T cells or cancer cells include programmed death (PD)-1, PD-ligand 1 (PD-L1), and cytotoxic T-lymphocyte–associated antigen (CTLA)-4/B7-1/B7-2. Merkel cell carcinoma: A rare, aggressive skin cancer. 1

Metastasis: The spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread. Monoclonal antibody: A protein developed in the laboratory that can locate and bind to specific substances in the body and on the surface of cancer cells. Programmed death (PD)-1 proteins: PD-1 proteins are found on T-cells and attach to PD ligands (PD-L1) found on normal (and cancer) cells (see immune checkpoint inhibitor above). Normally, this process keeps T-cells from attacking other cells in the body. However, this can also prevent T-cells from attacking cancer cells in the body. Examples of FDA approved anti-PD-1 agents include Keytruda (pembrolizumab), Opdivo (nivolumab), and Libtayo (cemiplimab). Programmed death ligand (PD-L)-1: The ligands found on normal (and cancer) cells to which the PD-1 proteins attach (see immune checkpoint inhibitor above). Cancer cells can have large amounts of PD-L1 on their surface, which helps them to avoid immune attacks. Examples of FDA approved anti-PD-L1 agents include Bavencio (avelumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab). Urothelial carcinoma: A type of bladder cancer which occurs in the urinary tract system. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.
Bavencio (avelumab) Requests for Bavencio (avelumab) may be approved if the following criteria are met: I. Individual is 12 years of age or older; AND A. B. C. D. Individual has a diagnosis of metastatic Merkel cell carcinoma (Label NCCN 2A); AND Individual has a current ECOG performance status of 0-2; AND Individual has not received treatment with another anti-PD-1 or anti-PD-L1 agent; AND Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant;

OR

II. OR III. OR IV. Individual has a diagnosis of locally advanced or metastatic Urothelial Carcinoma (Label, NCCN 1); AND A. B. C. Individual is using agent as monotherapy; AND Individual has a current ECOG performance status of 0-2; AND Individual meets one of the following:

1. Individual is using after platinum-containing chemotherapy (either as subsequent therapy after disease progression during or following platinum regimen, or as maintenance therapy following completion of platinum regimen with no evidence of disease progression); OR Has confirmed disease progression within 12 months of receiving neoadjuvant or adjuvant treatment with platinum-containing chemotherapy;

   2. AND D. E. Individual has not received treatment with another anti-PD-1 or anti-PD-L1 agent; AND Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic
      immunosuppressant;
      Individual has a diagnosis of endometrial carcinoma (NCCN 2A); AND A. Individual is using for recurrent or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors; AND Individual is using as monotherapy; AND Individual is using as second-line treatment or subsequent therapy; AND Individual has a current ECOG performance status of 0-2; AND Individual has not received treatment with another anti-PD1 or anti-PD-L1 agent; AND Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; B. C. D. E. F. Individual has a diagnosis of advanced Renal Cell Carcinoma (RCC) (Label, NCCN 2A); AND A. B. C. D. E. Individual is using as first-line therapy; AND Individual is using in combination with axitinib (Inlyta); AND Individual has histological confirmation of RCC with clear cell component; AND Individual has a current ECOG performance status of 0-2; AND Individual has not received treatment with another anti-PD-1 or anti-PD-L1 agent; AND
      2

   F. Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant.
   Requests for Bavencio (avelumab) may not be approved when the above criteria are not met and for all other indications. Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J9023 ICD-10 Diagnosis C4A.0-C4A.9 C54.1 C61 C64.1-C64.9 C65.1-C65.9 C66.1-C66.9 C67.0-C67.9 C68.0 C7B.1 Z85.51 Z85.59 Document History Injection, avelumab, 10 mg [Bavencio] Merkel cell carcinoma Malignant neoplasm of endometrium Malignant neoplasm of prostate Malignant neoplasm of kidney Malignant neoplasm of renal pelvis Malignant neoplasm of ureter Malignant neoplasm of bladder Malignant neoplasm of urethra Secondary Merkel cell carcinoma Personal history of malignant neoplasm of bladder Personal history of malignant neoplasm of other urinary tract organ Revised: 02/24/2023